title: Recombinant activated factor VII in patients with acute liver failure with UNOS Status 1A: a single tertiary academic centre experience.
abstract: OBJECTIVE
  Recombinant activated factor VII (rFVIIa) is often used in off-label indications, including many situations in which the patients are at risk of thrombosis. In this study, we retrospectively reviewed the use of rFVIIa in patients with acute liver failure - UNOS Status 1A (ALF-1A) to determine its efficacy and safety profile.
  
  
  METHODS
  Using the transplantation records, all adult patients with ALF-1A were identified from 6/2001 to 3/2009. From patients' medical charts, rFVIIa dose, blood component usage, short-term outcomes [length of intensive care unit (ICU) and hospital stay, ability to undergo orthotopic liver transplant (OLT) and in-hospital survival rate] and adverse events were examined.
  
  
  RESULTS
  Forty-two patients with ALF-1A were identified. Fifteen patients received rFVIIa with doses ranging between 24·4 μg/kg and 126·8 μg/kg. Three patients received two doses of rFVIIa. The age, baseline activated partial thromboplastin time (aPTT) and platelet (PLT) count were not statistically different between the group receiving rFVIIa versus the group that did not. However, the prothrombin time (PT) was significantly higher in the rFVIIa group. Although the rFVIIa group stayed in the ICU longer and required significant more blood products during admission, there was no statistical difference between the two groups in terms of length of hospital stay, ability to undergo OLT and survival rate. There was no increase in complications, including thrombosis, after receiving rFVIIa.
  
  
  CONCLUSIONS
  Recombinant activated factor VII (rFVIIa) appears to be safe in patients with ALF-1A, but to elucidate its full role, a randomized controlled trial would be ideal.
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center and the New York-Presbyterian Hospital, New York, NY, USA.
authors.forename: H P
authors.initials: HP
authors.lastname: Pham
authors.forename: S X
authors.initials: SX
authors.lastname: Hsu
authors.forename: S
authors.initials: S
authors.lastname: Parker-Jones
authors.forename: B
authors.initials: B
authors.lastname: Samstein
authors.forename: D
authors.initials: D
authors.lastname: Diuguid
authors.forename: J
authors.initials: J
authors.lastname: Schwartz
mesh_terms: D000328:Adult; D016913:Blood Component Transfusion / Q000009:adverse effects; D015942:Factor VIIa / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007362:Intensive Care Units; D017114:Liver Failure, Acute / Q000150:complications*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: Novoseven; acute fulminant hepatic failure; recombinant activated factor VII; transfusion